Regulatory Affairs Specialist

    Marshfield Clinic
    Marshfield, WI
    Full-time

    Job Description

    Come work at a place where innovation and teamwork come together to support the most exciting missions in the world!

    Job Title:Regulatory Affairs Specialist

    Cost Center:821415 MCRI-Clinical Research Center

    Scheduled Weekly Hours:40

    Employee Type:Regular

    Work Shift:Mon-Fri; 8:00 am - 5:00 pm (United States of America)

    Job Description:

    JOB SUMMARY

    The Regulatory Affairs Specialist performs a variety of administrative duties to facilitate accurate and continuous flow of regulatory information. The individual will contribute to regulatory submissions and regulatory/scientific strategy relevant to the assigned projects and serve on project teams.

    JOB QUALIFICATIONS

    EDUCATION/EXPERIENCE

    For positions requiring education beyond a high school diploma or equivalent, educational qualifications must be from an institution whose accreditation is recognized by the Council for Higher Education and Accreditation.

    Minimum Required:
    • Bachelor's degree in a physical, biological, social science, or related field, AND one years' experience in a medical or research field.
    • Associates degree (or completion of 60 college credits) in a physical, biological, social science, or related field, AND three years' experience in a medical or research field.
    • Completion of 30 credits post high school education in a physical, biological, social science, or related field, AND five years' experience in a medical or research field.
    • High school diploma AND seven years' experience in a medical or research field.
    Preferred/Optional: Bachelor's degree in Clinical Research and one years' experience in a human subject's research field within an academic medical center, university, or corporation within the healthcare field.

    CERTIFICATIONS/LICENSES

    The following licensure(s), certification(s), registration(s), etc., are required for this position. Licenses with restrictions are subject to review to determine if restrictions are substantially related to the position.

    Minimum Required:
    • Human Subjects Protection and Good Clinical Practice training through the Collaborative Institutional Training Initiative (CITI) within 90 days of hire.
    • Certified Clinical Research Coordinator Certification through Association of Clinical Research Professionals (ACRP) or through Society of Clinical Research Associates (SoCRA) within 6 months of qualification.
    • Other Certifications/Licenses as listed per the department the position resides in.
    Preferred/Optional:

    Certified Clinical Research Coordinator Certification through Association of Clinical Research Professionals (ACRP) or through Society of Clinical Research Associates (SoCRA).

    Marshfield Clinic Health System is committed to enriching the lives of others through accessible, affordable and compassionate healthcare. Successful applicants will listen, serve and put the needs of patients and customers first.

    Exclusion From Federal Programs: Employee may not at any time have been or be excluded from participation in any federally funded program, including Medicare and Medicaid. This is a condition of employment. Employee must immediately notify his/her manager or the Health System's Compliance Officer if he/she is threatened with exclusion or becomes excluded from any federally funded program.

    Marshfield Clinic Health System is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

    Posting ID: 552627702Posted: 2020-05-27